MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD POWERMIDLINE CATHETER BASIC KIT (4F) (SINGLE-LUMEN) (20CM)

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Swelling/ Edema (4577)

Event Date 10/14/2023

Event Type  malfunction  

Manufacturer Narrative

H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The device has not been returned to the manufacturer for evaluation.

Event Description

It was reported by the customer that a check-up of the right humeral midline was requested on 11/10, on which there was no reflux with a suspicious edamatous arm.Radiological examination revealed a perforated midline, with extravascular extravasation of waste product.The midline is removed.Delay in patient care or prolongation of hospital stay.

Manufacturer Narrative

H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The complaint of a leak is unconfirmed and could not be reproduced.One 4fr sl powermidline catheter was returned for evaluation.During the investigation of the returned sample a defect or damage was not found.The sample was flushed and pressurized without a leak observed.Due to not being able to reproduce the complaint, this investigation is unconfirmed.This complaint will be recorded for future trending and monitoring purposes.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported by the customer that a check-up of the right humeral midline was requested on 11/10, on which there was no reflux with a suspicious edamatous arm.Radiological examination revealed a perforated midline, with extravascular extravasation of waste product.The midline is removed.Delay in patient care or prolongation of hospital stay.

• Brand Name: BARD POWERMIDLINE CATHETER BASIC KIT (4F) (SINGLE-LUMEN) (20CM)
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18230120
• MDR Text Key: 329272670
• Report Number: 3006260740-2023-05398
• Device Sequence Number: 1
• Product Code: PND
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: P6154118
• Device Lot Number: REHQ1854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other